Surgical stapler with an end effector support

Contents of disclosure

0001[Field of invention] The present invention relates generally to surgical devices, in particular to surgical staplers and / or cutters having supports for end effectors.

0002[Background of invention] Endoscopic and laparoscopic surgical instruments are often preferred over conventional open surgical devices. This is because the use of natural openings (endoscopic) or small incisions (laparoscopic) can help reduce postoperative recovery time and reduce complications. As a result, significant developments have been made to the extent that endoscopic and laparoscopic surgical instruments are suitable for accurately placing distal end effectors at the desired surgical site. Such distal end effectors engage tissue in many ways and have diagnostic or therapeutic effects (eg, end cutters, foreign forceps, cutters, staplers, clip appliers, access devices (access). device), drug / gene therapy delivery device, and energy device using ultrasound, RF, laser, etc.).

0003Endoscopic and laparoscopic surgical staplers typically have a stapler that is stapled through the cannula to position the end effector with respect to the tissue to be stapled. It is configured. The end effector has a cartridge arm containing a cartridge with staples and an anvil connected to the cartridge arm so as to rotate around the axis. The cartridge arm and anvil each act as separate jaws, together to close and hold the tissue to be stapled. When the cartridge is activated, the staples are ejected from the cartridge arm, pass through the tissue, and hit the staple forming grooves that are formed in the anvil and aligned with the staples of the cartridge arm, thereby keeping the structure aligned. Mold the staples.

0004The anvil may bend when the stapler fires multiple staples in a straight line at the same time. Specifically, the relatively long, unsupported anvil length plus the force required to launch the staples can generate a large torque at the distal end of the anvil, which can cause deflection. As a result, the staples may become malformed, especially towards the distal end of the relatively long end effector. Endoscopic or laparoscopic procedures utilize small openings or access ports, which inevitably limits the thickness and outer diameter of the end effector. Even if very hard materials (eg steel or titanium) are used for the anvil, the deflection when the stapler is activated is significant.

0005Therefore, there is a need to improve the equipment and methods of stapling and / or cutting the tissue.

0006[Outline of Invention] The present invention generally provides methods and devices for supporting anvils of surgical staplers and / or cutters. In one embodiment, the surgical stapler is axially connected to an end effector having a cartridge arm for holding one or more staples and is effective in deforming the staples. May include anvils that are. The device may also include a support that contacts the end effector as one or more staples are ejected from the cartridge arm and deformed against the anvil. It is configured to reduce the deflection of the. In a typical embodiment, the cartridge arm may be configured to hold a plurality of staples in at least one straight row. The end effector and support also, in other embodiments, have a maximum outer diameter of less than about 16 mm when the support is in the folded position, and the end effector is placed in a small opening or orifice. Is possible.

0007The support may have a variety of structures, but in some embodiments it may be configured to contact the anvil at a position distal to the axis of rotation. For example, the support is slidably connected to the anvil between a proximal position where the anvil can move around the axis of rotation and a distal position where the support prevents the anvil from moving around the axis of rotation. Can be made movable with. In a typical embodiment, the support has at least two links that are axially connected to each other, one of which is slidably connected to the anvil. Specifically, the support is connected to a distal link that is slidably connected to the anvil, at one end so that it rotates axially to the distal link, and at the other end that is a cartridge. A proximal link that is axially rotated to an elongated shaft extending proximally from the arm, and one end that is axially connected to an elongated shaft and is connected to the opposite end. May have a distal link and a central link that is axially connected to the proximal link. In other embodiments, the support may be in the form of a sleeve, which has a first position in which the anvil is axially rotatable with respect to the cartridge arm and the anvil is axially rotatable with respect to the cartridge arm. It is movable to and from the second position to prevent it. In other embodiments, the device may include a stop member that limits the distal movement of the support. For example, anvils may have at least one elongated slot for slidably accepting at least one pin member formed on the support. This slot terminates at the substantially central portion of the anvil and may limit the distal movement of the support.

0008It also provides a typical method for stapling tissue. In one embodiment, the tissue is placed between the cartridge arm and the anvil of the surgical stapler, and the support is advanced relative to the anvil to eject one or more staples from the cartridge and the anvil and the cartridge arm. Includes a step of passing through the interstitial tissue, deforming the staples against the anvil, and preventing the anvil from flexing against the cartridge arm when the tissue is stapled.

0009The present invention can be understood in more detail by referring to the following detailed description together with the accompanying drawings.

0010[Detailed description of the invention] Generally, a surgical stapler and / or a cutter having an end effector for feeding staples to a tissue and a support for preventing the end effector from bending is provided. Specifically, the end effector is connected to the cartridge arm configured to support the staples so as to rotate around the axis, and is configured to deform the staples ejected from the cartridge arm. May have with anvils that have been. The support may be connected to an end effector, and the support has a first folding position where the anvil arm can rotate axially with respect to the cartridge arm, and the support is engaged with the anvil. When one or more staples are launched from the cartridge arm and deformed against the anvil, they may be movable to and from a second extension position that substantially limits the deflection of the anvil. Supports are particularly useful when used with slender and long surgical staplers and / or cutters that have one or more linearly aligned staple rows or relatively long end effectors that feed staple lines. This is because the support can substantially prevent bending of the distal end of the anvil while attaching a long line of multiple staples. For example, surgical staplers may have end effectors in the range of about 60 mm to 90 mm in length. The support is also particularly effective when used in endoscopic and laparoscopic procedures. This is because the supports can be folded and the end effectors and supports can be introduced through natural openings (eg, throat) or through small access ports such as cannulas and other small paths. .. For example, in a typical embodiment, the end effector and support may have a maximum outer diameter of less than about 16 mm when the support is in the folded position, with the support having a diameter of about 16 mm or less. May be possible to insert via a path with To. As will be appreciated by those skilled in the art, this support can be used in a variety of fastener transfer devices, and the linear staplers disclosed herein are for reference purposes only.

0011FIG. 1 shows a typical embodiment of a surgical stapler 10 having a support 30 for limiting or preventing anvil deflection. As shown, the device 10 typically has a handle 14 with an elongated shaft 12, which extends from the handle 14 and has a proximal end 12a and a distal end 12b. It is shown that the housing 13 of the shaft is arranged so as to cover a part of the elongated shaft 12. The staple application assembly, the end effector 20, is formed at the distal end 12b of the elongated shaft 12. The end effector 20 has arms facing each other, called cartridge arms 24 and anvil 22. The cartridge arm 24 and the anvil 22 are connected by a rotation shaft 26 so as to rotate about each other at their proximal ends. Further, the cartridge arm 24 and the anvil 22 are configured to receive the tissue between them. The cartridge arm 24 is configured to accommodate a staple cartridge having a plurality of staples. A plurality of staples are arranged in this staple cartridge and are configured to be driven into the tissue. Further, the anvil 22 includes a plurality of grooves, and these grooves are formed in the anvil 22 so as to deform the staples. The device 10 may have one or more triggers. These triggers act to activate the end effector 20, eg, to open and close the jaws of the end effector, and / or to move the cutting blade through the end effector 20. It is connected to the device 10. FIG. 1 shows a first trigger 14a movably connected to a handle 14 to close the facing jaws of the end effector 20. Handle 14 also has a second trigger 14b, which is used to fire the staple cartridge and send one or more staples to the tissue. It is movably connected to the handle 14. The second trigger, 14b, may also be effective in cutting the stapled tissue by advancing the blade distally through the staple cartridge. Although two triggers 14a and 14b have been shown, the handle 14 has other actuating mechanisms, such as rotary knobs, levers, slides, to actuate the end effector 20 in addition to or in place of the above. It may also have a knob. As will be appreciated by those skilled in the art, the device may have various other features not disclosed herein. For example, the device may include an articulated connection formed between the elongated shaft 12 and the end effector 20 so that the end effector 20 can be moved angularly with respect to the elongated shaft 12. .. A trigger or other mechanism can also be provided on the handle to adjust the angular orientation of the end effector 20.

0012The support portion 30 is shown in detail by FIGS. 2A to 2D. As shown in the figure, the support portion 30 is in the form of a link assembly, and is movably connected between the elongated shaft 12 and the anvil 22. Specifically, the support portion 30 has a proximal link portion 32, a distal link portion 34, and an intermediate link portion 36, and the proximal link portion 32, the distal link portion 34, and the intermediate link portion 36 are connected to each other. It is connected so as to rotate about the axis, and is movable with respect to the elongated shaft 12 and the end effector 20. The proximal link 32 has a proximal end 32a (FIG. 2D), which is axially rotated and slidably connected to a portion of the elongated shaft 12. Further, the proximal link portion 32 has a distal end 32b, and the distal end 32b is connected to the proximal end 34a of the distal link portion 34 so as to rotate axially. The distal link 34 extends distally from the distal end 32b of the proximal link 32, and the distal link 34 is axially rotated and slidably connected to the anvil 22. Has a distal end 34b. There are various sliding and axially rotating connections between the proximal end 32a of the proximal link 32 and the elongated shaft 12b, and between the distal end 34b of the distal link 34 and the anvil 22. It can be formed by using various methods. For example, the proximal link 32 is one of an elongated shaft 12 that slides, for example, like the sliding push rod 50 (FIG. 2D) and allows relative axial rotation of the proximal link 32. Can be connected to the part. The distal link 34 may also have a pin member that slides within the slot 22c formed in the anvil and also allows the distal link 34 to rotate axially with respect to the anvil 22. .. As described above, the support portion 30 may further have an intermediate link portion 36. As shown in FIGS. 2C and 2D, the intermediate link 36 is located at the first end 36a, at the distal end 32b of the proximal link 32, and at the proximal end 34a of the distal link 34. It is pivotally connected so that all three links 32, 34, and 36 are pivotally connected to each other in the central portion of the support 30. The second end portion 36b of the intermediate link portion 36 is connected to the elongated shaft 12 so as to rotate around the elongated shaft 12 at the fixed rotating shaft 36c, whereby the intermediate link portion 36 is connected to the elongated shaft portion 36 so as to rotate.It is not possible to slide against the foot 12.

0013In use, the connection between the links 32, 34, 36 allows the support 30 to have one or more of the support 30 from the cartridge arm 24 with a proximal fold position where the anvil 22 can rotate about the axis of the cartridge arm 24. When the staples are launched and deformed against the anvil 22, the support 30 can move to and from a distal, extended position that is effective in limiting or preventing deflection of the anvil 22. Proximal folding positions are shown in FIGS. 2A and 2B, and as shown, the links 32, 34, 36 are substantially axially aligned with the end effector 20 and are elongated shafts. 12, the maximum outer diameter of the end effector 20, and the support 30 is substantially constant over its entire length, and the distal portion of device 10 is inserted through a small path, eg, a path with a diameter of 16 mm or less. You can do it. Specifically, as will be described in more detail later, for example, a trigger formed on the handle of the staple or other mechanism is used to completely retract the proximal link 32 in the proximal direction to the distal link. Pull the portion 34 proximally so that the distal end 34b of the distal link portion 34 is most proximal to the anvil 22. When the proximal link portion 32 is retracted to the proximal side, the first end portion 36a of the intermediate link portion 36 (not shown in FIGS. 2A and 2B) also rotates axially in the proximal direction, and the intermediate link portion 36 will be accepted into the openings provided in the elongated shaft 12. In this position, the anvil 22 can be freely opened and closed with respect to the cartridge arm 24. FIG. 2A illustrates an anvil 22 in an open position to receive tissue in between, and FIG. 2B illustrates an anvil 22 in a closed position to engage tissue in between. A separate closure mechanism can be used to move the anvil 22 to the closed position shown in FIG. 2B, or when the support 30 is moved to the distal extension position, the support 30 can be used to move the anvil. 22 can also be pressed against the cartridge arm 24.

0014The support 30 is shown in FIGS. 2C and 2D in a distal extension position. As shown, the proximal link 32 is moved distally towards the end effector 20, for example, using a trigger or other mechanism formed on the staple handle, as described in more detail later. .. By moving the proximal link portion 32 toward the distal end, the first end portion 36a of the intermediate link portion 36 is fixed formed between the second end portion 36b of the intermediate link portion 36 and the elongated shaft 12. The axis rotates around the axis of rotation 36c. When the first end 36a of the intermediate link 36 moves away from the elongated shaft 12 and rotates around the fixed rotation axis 36c, the proximal end 34a of the distal link 34 also moves away from the elongated shaft 12. That is, it rotates with respect to the elongated shaft 12, and the distal end 34b of the distal link 34 slides distally within the elongated slot 22c formed in the anvil 22. When the distal link 34 reaches its most distal position, the force exerted on the proximal link 32 no longer advances the distal link 34, but rather the distal link 34 exerts on the anvil 22. It is a downward force that limits or prevents the anvil 22 from flexing against the cartridge arm 24 when the staples are driven from the cartridge arm 24 into the anvil 22.

0015The support 30 can be engaged with any portion of the anvil 22, but in a typical embodiment the support 30 can be configured to engage with a substantially central portion of the anvil 22. .. Such a configuration ensures that the distal link 34 exerts a downward force on the anvil 22, which may optionally be effective in moving the anvil to a closed position. Engagement of the anvil 22 with the central portion can be achieved, for example, by using a stop member to limit the distal movement of the support 30 with respect to the anvil 22. In the embodiments shown in FIGS. 2C and 2D, the end point 22d of the elongated slot 22c formed in the anvil 22 functions as a stop member. This is because this slot 22c terminates proximally to the most distal end of the anvil 22. Thus, the endpoint 22d prevents the distal link 34 from sliding distally beyond the most distal end of slot 22c, thereby causing the distal link 34 to slide distally over the central portion of the anvil 22. Engage with. The end point of the slot can also be adjusted using a movable stop pin. The slot may have multiple locations where stop pins can be inserted, and the position of the stop pins is such that the distal link is at the distal end of the anvil before the distal link can no longer slide. You can decide the range that you can slide toward. As will be appreciated by those skilled in the art, a variety of other techniques can be used to create stops or other mechanisms that limit the distal movement of the support.

0016As mentioned above, the support 30 can be moved between the proximal and distal positions using a variety of techniques. For example, in one embodiment, the proximal link can be connected to a push rod 50 (FIG. 2D) in an axial rotation, which extends through an elongated shaft 12 and is elongated. It is configured to slide with respect to the shaft 12 to move the proximal link 32 forward and backward, thereby moving the support 30 between the proximal and distal positions. A lever, trigger, or other mechanism formed on the handle of the device can be provided to move the push rod 50. As will be appreciated by those skilled in the art, the movement of the support and / or the axial rotation of the anvil and the cartridge arm may be simultaneous with each other or independently, and the staples may be fired from the cartridge arm 34. It may be done independently of doing.

0017The support can also have a variety of other structures to prevent the anvil on the surgical stapler from bending. In another embodiment, as shown in FIGS. 3A-3C, the support is in the form of a sleeve that is relatively movable relative to the end effector between the first and second positions. Sometimes. As shown, the surgical stapler 300 typically has an elongated shaft 310, which has an end effector. The end effector is formed at the distal end of the elongated shaft 310 and has an anvil 320 and a cartridge arm 330 that is axially coupled to the anvil 320. The sleeve 340 is slidably located within the outer housing of the elongated shaft 310, with a proximal retracted position (shown in FIG. 3A) and a distal extended position (shown in FIG. 3B). It is movable between. The sleeve 340 can have a variety of shapes and sizes and may be substantially tubular, or it may have an overall elongated shape, as shown in FIGS. 3A and 3B. The cross section may be substantially semicircular. When the sleeve 340 is in the proximal position as shown in FIG. 3A, the sleeve 340 is fully retracted with respect to the anvil 320, allowing the anvil 320 to rotate axially with respect to the cartridge arm 330. When the sleeve 340 is advanced to the distal position, the sleeve 340 slides over the anvil and contacts the anvil 320 at a position distal to the axis of rotation 350, which causes the anvil 320 to move into the cartridge arm 330. Prevents, that is, prevents, the axial rotation movement. Therefore, when the staples are fired, the sleeve 340 limits or prevents the anvil 320 from flexing.

0018Similar to the embodiments shown in FIGS. 2A to 2D, the operation of the support sleeve 340 can be realized in various ways. In one embodiment, the handle 370 of the device 300 includes a sliding button 360, as shown in FIG. 3C. The sliding button 360 is formed on the handle 370 and is connected to the proximal end of the sleeve 340. Thus, the movement of the sliding button 360 between the proximal and distal positions is effective in moving the sleeve 340 between the proximal and distal positions.

0019As will be appreciated by those skilled in the art, the sleeve may have a variety of other configurations, and the sleeve does not need to move between retracted and extended positions. For example, the sleeve has a first position where the sleeve is in the vicinity of the cartridge arm and allows axial rotation of the anvil and the cartridge arm, and the sleeve is in the vicinity of the anvil and the anvil is axially rotated with respect to the cartridge arm. It may be rotatable to and from a second position to limit or prevent.

0020It also provides a typical method of stapling tissue. In certain typical embodiments, the method comprises introducing an end effector of a surgical stapler into the surgical site. The end effector may be inserted through a natural opening with an endoscope or through a small incision or a cannula-like access port with a laparoscope. You can also do it. The end effector is preferably inserted with the support in a retracted position where the outer diameter of the device's elongated shaft is minimal or maintained to a minimum. For example, with respect to the device 10 shown in FIGS. 2A-2D, the support 30 is preferably introduced in the proximal folding position. With respect to the embodiments shown in FIGS. 3A to 3C, the support sleeve 340 can be installed in any position. This is because the sleeve 340 does not increase the outer diameter of the device.

0021Once the end effector is placed near the tissue to be stapled, the anvil and cartridge arm are operated to place the tissue in between. The anvil is then turned towards the cartridge arm and the tissue is sandwiched between the anvil and the cartridge arm, for example using a support or using a separate closing mechanism. If the support is not used to close the anvil, then the support can be advanced to prevent or prevent the anvil from moving against the cartridge arm. Optionally, the tissue may be crushed for a period of time to "milk" the tissue, after which the end effector is activated and staples are ejected from the cartridge arm to the tissue between the anvil and the cartridge arm. You can hit the anvil through it. The staples will deform upon hitting the anvil and the support will prevent the anvil from bending.

0022Those skilled in the art will appreciate other features and advantages of the invention based on the embodiments described above. Therefore, the present invention is not limited to what has been specifically illustrated and described, except as indicated by the appended claims.

0023[Implementation mode] (1) In a surgical stapler An end effector having a cartridge arm for holding at least one staple and an anvil that is axially rotated and connected to the cartridge arm and is effective in deforming the at least one staple. A support that is connected to the end effector, the proximal position where the anvil and the cartridge arm can rotate axially with respect to each other, and the support is engaged with at least the central portion of the end effector. A support and a support that is movable between a distal position that prevents the anvil from flexing relative to the cartridge arm when at least one staple is ejected from the cartridge arm and deformed against the anvil. Surgical stapler equipped with.

0024(2) In the surgical stapler according to the first embodiment. When in the proximal position, the support is axially aligned with the end effector, and when in the distal position, it extends substantially laterally with respect to the end effector. There is a surgical stapler. (3) In the surgical stapler according to the first embodiment. The support is a surgical stapler that includes a link mechanism that is slidably connected to the anvil. (4) In the surgical stapler according to the third embodiment. The link mechanism A proximal link portion connected so as to rotate about an elongated shaft extending in the proximal direction from the end effector, and a proximal link portion. A distal link that is axially rotated to the proximal link at one end and axially rotated to the anvil at the opposite end. including, Surgical stapler.

0025(5) In the surgical stapler according to the fourth embodiment. A surgical stapler in which the distal link portion is connected to the anvil at a position distal to the axial rotation connecting portion formed between the anvil and the cartridge arm. (6) In the surgical stapler according to the first embodiment. The support is a surgical stapler that includes a sleeve that can be slidably placed over at least a portion of the anvil. (7) In the surgical stapler according to the first embodiment. An actuating unit that is connected to the end effector and is configured to push the anvil towards the cartridge arm. Surgical stapler with more features. (8) In the surgical stapler according to the first embodiment. The support portion is a surgical stapler configured to press the anvil toward the cartridge arm.

0026(9) In a surgical stapler With a cartridge arm that is configured to hold multiple staples, An anvil having a proximal end and a distal end, wherein the proximal end is connected to the cartridge arm on a rotation axis. A support portion movably connected to the anvil, which comes into contact with the anvil at a position distal to the rotation axis, and a plurality of staples are ejected from the cartridge arm and deformed by hitting the anvil. Sometimes, with a support, which is configured to reduce the deflection of the anvil, Surgical stapler equipped with. (10) In the surgical stapler according to the ninth embodiment. The support can move between a proximal position where the anvil can move around the axis of rotation and a distal position where the support prevents the anvil from moving around the axis of rotation. , Surgical stapler.

0027(11) In the surgical stapler according to the ninth embodiment. The surgical stapler, wherein the support has at least two links that are axially connected to each other, and at least one of the links is slidably connected to the anvil. (12) In the surgical stapler according to the ninth embodiment. The support portion A distal link that is slidably connected to the anvil, At one end, it is pivotally connected to the distal link, and at the other end, it is pivotally connected to an elongated shaft extending proximally from the cartridge arm. Proximal link and An intermediate link portion which is connected to the elongated shaft portion so as to rotate axially at one end and is connected to the distal link portion and the proximal link portion so as to rotate axially at the opposite end portion. When, Is equipped with Surgical stapler.

0028(13) In the surgical stapler according to the ninth embodiment. A stop, which is configured to limit the distal movement of the support with respect to the anvil. Surgical stapler with more features. (14) In the surgical stapler according to the thirteenth embodiment. The stop is The elongated slot formed in the anvil and A pin member that is connected to the support and is slidably arranged in the elongated slot. including, Surgical stapler. (15) In the surgical stapler according to embodiment 14. A surgical stapler in which the elongated slot in the anvil terminates proximally to the distal end of the anvil.

0029(16) In the surgical stapler according to the ninth embodiment. The support is a surgical stapler that includes a sleeve that can be slidably placed over the anvil. (17) In the surgical stapler according to the ninth embodiment. A surgical stapler comprising a staple cartridge, wherein the staple cartridge is located within the cartridge arm and contains a plurality of staples arranged in at least one straight row. (18) In the surgical stapler according to the ninth embodiment. The cartridge arm and the anvil are surgical staplers having a length of at least 60 mm.

0030(19) In the surgical stapler according to the ninth embodiment. The cartridge arm and the anvil are surgical staplers having a length of at least 90 mm. (20) In the surgical stapler according to the tenth embodiment. The cartridge arm, the anvil, and the support are surgical staplers having a maximum outer diameter of less than 16 mm when the support is in a proximal position. (21) In the method of stapling the tissue The stage of placing tissue between the surgical stapler cartridge and the anvil, A step of advancing the support with respect to the anvil to prevent the anvil from moving with respect to the cartridge. A step of ejecting at least one staple from the cartridge, passing it through a tissue arranged between the anvil and the cartridge, and applying the staple to the anvil to deform the staple to staple the tissue. Including methods.

0031(22) In the method described in embodiment 21, A method of inserting the surgical stapler through an access tube prior to placing the tissue. (23) In the method described in embodiment 21, A method of impinging the tissue between the anvil and the cartridge for a user-determined period before embossing at least one staple. (24) In the method described in embodiment 21, The method, wherein the step of launching the at least one staple includes a step of launching a plurality of staples arranged in at least a row.

<figref num="1">It is a side view of the surgical stapler by one Embodiment of this invention.</figref><figref num="2A">It is a perspective view of the end effector of the surgical stapler of FIG. 1, and shows one embodiment of a support portion in a folded position and an anvil which is rotated about an axis and separated from a cartridge arm.</figref><figref num="2B">FIG. 2A is a perspective view of the end effector, showing the support in the folded position, and the anvil and cartridge arm that are axially rotated together.</figref><figref num="2C">FIG. 2A is a perspective view of the end effector, showing a support portion at a position partially extended with respect to the anvil.</figref><figref num="2D">FIG. 2A is a perspective view of the end effector, showing a support in a fully extended position to prevent bending of the anvil.</figref><figref num="3A">It is a perspective view of another embodiment of the end effector of a surgical stapler, the end effector having an anvil connected to a cartridge arm so as to rotate around the axis, and a supporting sleeve. , Proximal to allow the anvil to rotate around the axis and away from the cartridge arm.</figref><figref num="3B">FIG. 3A is a perspective view of the end effector, showing anvils and cartridge arms that are axially rotated relative to each other, and a support sleeve that is advanced towards a distal position to impede the movement of the anvils.</figref><figref num="3C">FIG. 3A is a perspective view of the handle portion of the surgical stapler shown in FIG. 3A, showing a lever for moving the support between the proximal and distal positions.</figref>